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← All trials/NCT05040087

CHANGE

Active not recruitingPhase NA

Changing the Natural History of Type 2 Diabetes ("CHANGE" Study)

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

127

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 6-7.4%

Primary endpoints

•HbA1c, change•Β-CELL FUNCTION - PRIMARY OUTCOME #2a•Β-CELL FUNCTION - PRIMARY OUTCOME #2b

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05040087
Org study ID2107
Secondary ID1R01DK127083-01A1

Timeline

Milestones

Study start2021-09-01actual
Study first posted2021-09-10actual
Last update posted2025-05-06actual
Primary completion2027-01-31estimated
Study completion2027-03-31estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age40 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•diagnosis of diabetes by OGTT
•age 40-75 years
•HbA1c 6.0-7.4%
•1 hr OGTT glucose >155 mg/dl in each group

Exclusion criteria

•CVD event during the previous year
•systemic glucocorticoids
•bariatric surgery
•stage III-IV congestive heart failure
•severe angina
•life expectancy <5 years
•BMI >40 kg/m2
•pregnancy
•pancreatitis
•family or personal history of multiple endocrine neoplasia 2a
•an estimated glomerular filtration rate [eGFR] of ≤50 ml/min
•an alanine aminotransferase (ALT) level >3x the upper limit of the normal range
•dementia

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
5
Renal / kidney
2
Other clinical outcomes
1
Other (unclassified)
1

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

EFFECT SIZE

Time frame:2.75 years (includes 3 month washout)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint/low confidence

β-CELL FUNCTION - PRIMARY OUTCOME #2a

Time frame:2.75 years (includes 3 month washout)

descriptive

Primary/protocol endpoint/low confidence

β-CELL FUNCTION - PRIMARY OUTCOME #2b

Time frame:2.75 years (includes 3 month washout)

descriptive

Primary/protocol endpoint

β-CELL FUNCTION - PRIMARY OUTCOME #2c.

Time frame:2.75 years (includes 3 month washout)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Point of care glucose by continuous glucose monitoring (CGM)

Time frame:2.5 years

descriptive

Renal / kidney

2 endpoints
Secondary/protocol endpoint

NEPHROPATHY by eGFR

Time frame:2.5 years

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

NEPHROPATHY by urine microalbumin/creatinine ratio

Time frame:2.5 years

uACR, change

ratio, improvement

LOINC 9318-7

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

RETINOPATHY determined by fundus photographs

Time frame:2.5 years

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

COST EFFECTIVENESS - to be explored only if additional (ancillary) funding can be obtained

Time frame:2.5 years

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.